Use of Fish Oils to Reduce the Frequency and Duration of Episodes of Atrial Fibrillation in Patients With Paroxysmal Atrial Fibrillation.
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study is to investigate whether fish oil supplements may reduce the frequency and duration of paroxysmal atrial fibrillation episodes. Atrial fibrillation is a heart condition which effects a large percentage of the population . Atrial fibrillation is a condition frequently experienced by people who have had pacemakers inserted . Certain Pacemakers have sophisticated monitoring features that are able to recognise episodes of atrial fibrillation. Fish oil supplements may be of benefit to patients with heart problems.Recent evidence suggests that fish oils may be beneficial to patients with rhythm disturbances. By interrogating pacemakers this study will investigate the effect of fish oil supplements on the frequency and duration of episodes of atrial fibrillation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 atrial-fibrillation
Started Dec 2003
Longer than P75 for phase_4 atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 2, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedMay 30, 2013
February 1, 2013
9.1 years
October 2, 2005
May 28, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Atrial tachycardia and atrial fibrillation burden
18 months
Secondary Outcomes (1)
Frequency and duration of atrial tachycardia/fibrillation episodes
18 months
Other Outcomes (1)
Safety and tolerability of fish oil
18 months
Study Arms (2)
Fish oil
EXPERIMENTALPatients prescribed 6g/day of fish oil containing total 1.8 g of EPA+DHA in a 1.5:1 ratio
Control
NO INTERVENTIONNo fish oil exposure
Interventions
Eligibility Criteria
You may qualify if:
- Patients who have had at least 2 previous episodes of atrial fibrillation and an implanted pacemaker.
You may not qualify if:
- Patients with chronic atrial fibrillation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Melbourne Healthlead
Study Sites (1)
Royal Melbourne hospital
Melbourne, Victoria, 3050, Australia
Related Publications (1)
Kumar S, Sutherland F, Stevenson I, Lee JM, Garg ML, Sparks PB. Effects of long-term omega-3 polyunsaturated fatty acid supplementation on paroxysmal atrial tachyarrhythmia burden in patients with implanted pacemakers: results from a prospective randomised study. Int J Cardiol. 2013 Oct 9;168(4):3812-7. doi: 10.1016/j.ijcard.2013.06.030. Epub 2013 Jul 26.
PMID: 23890856DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Sparks
Melbourne Health
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2005
First Posted
October 4, 2005
Study Start
December 1, 2003
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
May 30, 2013
Record last verified: 2013-02